WO2025038457A1 - Appareil et procédé de réduction de symptômes de troubles neurologiques du mouvement à l'aide d'un dispositif pouvant être porté - Google Patents

Appareil et procédé de réduction de symptômes de troubles neurologiques du mouvement à l'aide d'un dispositif pouvant être porté Download PDF

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WO2025038457A1
WO2025038457A1 PCT/US2024/041732 US2024041732W WO2025038457A1 WO 2025038457 A1 WO2025038457 A1 WO 2025038457A1 US 2024041732 W US2024041732 W US 2024041732W WO 2025038457 A1 WO2025038457 A1 WO 2025038457A1
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sensor
subject
processing unit
actuator
stimulation
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Daniel Carballo
Kyle Pina
Allison Davanzo
Trang Luu
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Encora Inc
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Encora Inc
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Priority claimed from US18/448,385 external-priority patent/US20230381545A1/en
Application filed by Encora Inc filed Critical Encora Inc
Priority to AU2024324448A priority Critical patent/AU2024324448A1/en
Publication of WO2025038457A1 publication Critical patent/WO2025038457A1/fr
Anticipated expiration legal-status Critical
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H23/00—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms
    • A61H23/02—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive
    • A61H23/0245—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive with ultrasonic transducers, e.g. piezoelectric
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H23/00—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms
    • A61H23/02—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive
    • A61H23/0218—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive with alternating magnetic fields producing a translating or oscillating movement
    • A61H23/0236—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive with alternating magnetic fields producing a translating or oscillating movement using sonic waves, e.g. using loudspeakers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H23/00—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms
    • A61H23/02—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive
    • A61H23/0254—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive with rotary motor
    • A61H23/0263—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive with rotary motor using rotating unbalanced masses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/10—Characteristics of apparatus not provided for in the preceding codes with further special therapeutic means, e.g. electrotherapy, magneto therapy or radiation therapy, chromo therapy, infrared or ultraviolet therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16—Physical interface with patient
    • A61H2201/1602—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support
    • A61H2201/1635—Hand or arm, e.g. handle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16—Physical interface with patient
    • A61H2201/1602—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support
    • A61H2201/165—Wearable interfaces
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5007—Control means thereof computer controlled
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5058—Sensors or detectors
    • A61H2201/5084—Acceleration sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5097—Control means thereof wireless

Definitions

  • Parkinson’s Disease can cause tremor, rigidity, bradykinesia, and temporary freezing or inability to begin a motion. Restless Leg Syndrome does not cause a tremor; however, it causes a strong compulsion to move and shake the patient’s legs. Tremor can also be present as a side effect of certain medications. [0004] There are approximately 10 million people living with Parkinson’s Disease (PD) in the world today, and over 70% of these patients experience tremors - the involuntary trembling or shaking of the extremities.
  • Parkinson’s Disease has no cure. Treatments at the moment consist of medications to address patients’ symptoms, though these do not reverse the effects of the disease. Patients often take a variety of medications at different doses and different times of day to manage symptoms. PD medications are most often dopaminergic, either supplying or mimicking the effects of dopamine to replenish the depleted dopamine state caused by the disease. Attorney Docket No. ENR-001USCP3WO [0006] Surgical procedures can be prescribed for patients who have exhausted their medical treatment options.
  • the first method of surgical treatment is Deep Brain Stimulation (DBS).
  • DBS Deep Brain Stimulation
  • electrodes are inserted into the brain, and then an impulse generator battery is implanted under the collar bone or in the abdomen.
  • the patient uses a controller to power the device on or off, as needed, to help control tremors.
  • DBS can be effective for both Parkinson’s disease and essential tremor, but this procedure is incredibly invasive and expensive.
  • the second surgical procedure available for Parkinson’s patients is Duopa therapy.
  • Duopa therapy requires a small hole (a stoma) to be surgically made in the stomach to place a tube in the intestine.
  • Duopa which is similar to normal PD medications taken through pills, is then pumped directly into the intestine, which improves absorption and reduces off-times of medications taken by pill.
  • a similar disorder, called essential tremor has an even higher incidence rate with an estimated 100 million cases worldwide. These tremors can get bad enough that patients no longer have the ability to cut their food, tie their shoes, or sign their name.
  • Essential tremor medications can include beta blockers and anti-seizure medications. These medications are known to cause fatigue, heart problems, and nausea.
  • RLS Restless Leg Syndrome
  • RLS Restless Leg Syndrome
  • RLS is characterized by unpleasant tingling sensations in the patient’s legs. These sensations occur when the legs are still and are alleviated when the legs are in motion. As a result, RLS patients are compelled to move or shake their legs. This is particularly detrimental to the quality of patients’ sleep as they are unable to remain still.
  • RLS is commonly treated by dietary changes, medications, and/or physical therapy. Dietary changes can include eliminating caffeine, alcohol, and tobacco. Medications prescribed for RLS can include the same type of medications prescribed for Parkinson’s Disease (such as dopamine agonists and carbidopa-levodopa) and benzodiazepines (such as lorazepam, Xanax, Valium, and Ativan).
  • Physical therapy for RLS can include massaging the legs or electrical or vibrational stimulation.
  • One example of a device that uses vibration to treat RLS is described in “Systems, devices, and methods for treating restless leg syndrome and periodic limb movement disorder,” Attorney Docket No. ENR-001USCP3WO Walter, T. J., & Marar, U. (2010), U.S. Patent Application Publication No. US20100249637A1.
  • This device is a lower leg sleeve with sensors and actuators, but it does not store or transmit data, nor does it address any of the other symptoms common to neurological movement disorders.
  • a wearable device for mitigating a movement disorder of a subject.
  • the device includes an attachment system configured to be attached to a body part of a subject.
  • the device further includes a set of body part sensors to provide a set of sensor outputs related to a body part parameter.
  • the device also includes a processing unit operationally coupled to the set of body part sensors.
  • the processing unit is configured to quantify an extent or characteristic of the movement disorder based on the set of sensor outputs.
  • the device further includes a set of mechanical transducers operationally Attorney Docket No.
  • the attachment system includes a wristband, and the mechanical transducers are distributed throughout the circumference of the wristband.
  • the device is operated by a button on a face of the device, the button is configured on the face to allow for ease of use by a patient whose fine motor control is affected by a neurological movement disorder.
  • the wristband is configured with a hook-and-loop fastener, such that the wristband can be fastened with a single hand for ease of use by those whose fine motor control is affected by a neurological movement disorder.
  • the device further includes a battery that can be coupled to a magnetically aligned charging cable for charging the device, which provides ease of use by a patient whose fine motor control is affected by a neurological movement disorder.
  • the device is configured to be fully autonomous, using passive movement disorder sensing to initiate active operation.
  • the processing unit is further configured to use closed loop control, along with a state machine, to address symptoms.
  • the processing unit is further configured to control the mechanical transducers, without requiring control inputs from external control units.
  • the processing unit is further configured to collect and store data.
  • the symptoms are selected from the group consisting of tremor, rigidity, bradykinesia, compulsion to move, and combinations thereof.
  • the processing unit is further configured to detect a freezing gait of a patient with Parkinson’s Disease.
  • the processing unit is further configured to control the set of mechanical transducers so as to relieve freezing gait of a patient with Parkinson’s Disease.
  • Fig.1 illustrates a system for mitigating movement disorder in accordance with an embodiment of the present invention.
  • Fig.2 is an electrical schematic highlighting the main sub-circuits of the system in Fig.1.
  • Fig.3 is an isometric view of a wearable device in accordance with an embodiment of the present invention.
  • Fig.4 is an exploded isometric view of a wearable device, in which the vibration motors are housed in the band rather than in the main electronics housing, in accordance with an embodiment of the present invention.
  • Fig.5 is an isometric view of a wearable device, in which the device includes a loop mechanism to allow single handed adjustment of the band on the user’s wrist, in accordance with an embodiment of the present invention.
  • Fig.6 shows an embodiment of the present invention worn on a hand viewed from above.
  • Fig.7 shows an embodiment of the present invention worn on a hand viewed from the side.
  • Fig.8 shows a testing configuration for the wearable medical device, which may be used for more rigorous data collection, in accordance with an embodiment of the present invention.
  • Fig.9 illustrates a wearable device for mitigating movement disorder, in which the device is an accessory to a third-party smartwatch or other wearable computing device, in accordance with an embodiment of the present invention.
  • Fig.10 shows a side view of a wearable device, which is as an accessory band for a third-party smartwatch or other wearable computing device, in accordance with an embodiment of the present invention.
  • Fig.11 shows a process by which a raw sensor input may be used to compute a set of stimulation parameters in accordance with an embodiment of the present invention.
  • Fig.12 shows a feature extraction process in accordance with an embodiment of the present invention.
  • Fig.13 shows a stimulation optimization algorithm in accordance with an embodiment the present invention.
  • Fig.14 shows a neurological signal cancelling system, illustrating how the wearable device and body interact, in accordance with an embodiment of the present invention.
  • Attorney Docket No. ENR-001USCP3WO [0036]
  • Fig.15 is a pair of renderings by a Parkinson’s patient of a spiral under conditions without and with treatment by a device in accordance with an embodiment of the present invention.
  • Fig.16 illustrates an embodiment of a simple non-convex gradient descent optimization used in embodiment of the present invention for symptom reduction by searching over the parameter configuration space.
  • Fig.17 shows a power spectral density (PSD) plot of the postural tremor of a Parkinson’s Disease patient with and without the use of a device in accordance with an embodiment of the present invention.
  • Fig.18 shows a power spectral density (PSD) plot of the postural tremor of an Essential Tremor patient with and without the use of a device in accordance with an embodiment of the present invention.
  • PSD power spectral density
  • a “body part” is a part of a human body, such as a limb (examples of which include an arm, a leg, an ankle, and a wrist) or the neck.
  • a “body part sensor” is a sensor responsive to a parameter, associated with a body part, the parameter selected from the group consisting of force, motion, position, EMG signal directed to a set of muscles of the body part and combinations thereof.
  • a “mechanical transducer” is a device having an electrical input and a mechanical output configured to provide physical stimulation to a subject.
  • a “movement disorder sensor” is a sensor that is configured to provide a measurement associated with a neurological movement disorder.
  • An “attachment system” is a system or a device having a means to mechanically affix component subsystems to the user’s person.
  • a “housing” is a primary enclosed casing which contains one or more component subsystems.
  • Attorney Docket No. ENR-001USCP3WO [0048]
  • a “band” is a flexible segment of material which encircles a body part or portion of a body part for the purpose of affixment which may also house one or more component subsystems.
  • the term “vibrational stimulus” refers to a vibration or series of vibrations produced by a vibration motor or group of vibration motors embedded in the device.
  • stimulation pattern refers to a vibrational stimulus which is characterized by a number of parameters including frequency, amplitude, and waveform.
  • a “stimulation pattern” can also refer to a longer time scale behavior over which the above- mentioned parameters evolve over time.
  • proprioception refers to the sense of the position of one’s own limbs or body parts and the intensity of force being applied through that body part.
  • a proprioceptor is a sensory neuron which is used for proprioception.
  • neurological movement disorder refers to any of the neurological conditions that cause abnormally increased or decreased movements which may be voluntary or involuntary.
  • Ataxia cervical dystonia, chorea, dystonia, functional movement disorder, Huntington's disease, multiple system atrophy (MSA), paresis, hemiparesis, quadriparesis, post-stroke movement disorders, myoclonus, Parkinson's disease (PD), Parkinsonism, drug induced Parkinsonism (DIP), progressive supranuclear palsy (PSP), restless legs syndrome (RLS), tardive dyskinesia, Tourette syndrome, spasticity, rigidity, bradykinesia, tremor, essential tremor (ET), alcohol or drug withdrawal induced tremor, drug induced tremor, psychogenic tremor, rest tremor, action tremor, cerebellar lesion, rubral tremor, isometric tremor, task-specific tremor, orthostatic tremor, intention tremor, postural tremor, periodic limb movement disorder, and Wilson's disease.
  • the term “training period” refers to a period or phase of the device’s operation during which the device is conducting experimentation or collecting and analyzing data for the purpose of deducing the optimal stimulation pattern.
  • Attorney Docket No. ENR-001USCP3WO [0054]
  • the present disclosure is directed generally towards wearable medical devices and in particular towards the mitigation of tremors, rigidity, bradykinesia, involuntary rhythmic movements, and freezing associated with neurological movement disorders through mechanical vibrational stimulation of the tendon bundles in the wrist and autonomous sensing, feedback, and adjustment.
  • There are also a number of considerations taken into the embodiment of the device which facilitate ease of use by the disabled populations for whom the invention is intended, including integration with 3rd party devices.
  • Embodiments of the present disclosure include systems and methods of treating symptoms of neurological movement disorders by stimulating proprioceptors.
  • the systems are wearable devices.
  • the systems and methods can be used for any neurological movement disorder, including but not limited to Parkinson’s Disease, Essential Tremor, post-stroke movement disorders, or Restless Leg Syndrome.
  • the symptoms treated include tremor, rigidity, bradykinesia, stiffness, hemiparesis, and freezing.
  • the symptoms treated include muscle contraction caused by dystonia.
  • the symptoms treated include the inability to locate one’s limbs in space.
  • the proprioceptors targeted for stimulation are located in the wrist.
  • the proprioceptors targeted for stimulation are located in the ankle. In some embodiments, the proprioceptors targeted for stimulation are located in the neck. [0056] In some embodiments, the systems provide stimulus to the proprioceptive nerves (proprioceptors) for reducing symptoms by the use of vibration motors positioned around the surface of the wrist In some embodiments, the systems cycle through frequency patterns and waveforms of stimulation to find the pattern that results in the greatest reduction of movement disorder symptoms. In some embodiments, the systems use random white-noise subthreshold stimulation in order to leverage the effect of sensory stochastic resonance.
  • the systems are coupled to one or more sensors that measure the user’s tremor for each of a set of possible stimulation patterns, and the systems assign the pattern of stimulation that relates to the biggest measured decrease in tremor amplitude of that user relative to the tremor exhibited in the absence of stimulation
  • the device finds (learns) the optimal stimulation parameters for use in reducing the symptoms by using sensor-based optimization, including but Attorney Docket No. ENR-001USCP3WO not limited to model free reinforcement learning, genetic algorithms, Q-learning.
  • These parameters can include any quantities used to define a stimulation waveform such as frequency, amplitude, phase, duty cycle, etc.
  • these learned parameters also describe the longer time scale behavior of the stimulation pattern evolving over time.
  • the device determines the optimal stimulation as the weighted average of the optimal stimulations for each of the independent symptoms observed where the weights are proportional to the symptom severity relative to the other observed symptoms. For example, if the patient experienced tremors and rigidity, and the severity of the tremors was double that of the rigidity, the output stimulation would be two times the optimal tremor reducing pattern superposed with one times the optimal rigidity reducing pattern. In some embodiments, the device senses all of the active symptoms and elects to reduce only the symptom with the worst severity.
  • the device via sensors, measures the shaking due to RLS of the user and assigns the pattern that relates to the biggest decrease in shaking amplitude of that user where the amplitude is that of the sensor signal and the difference is defined relative to the amplitude observed in the absence of stimulation from the device.
  • the sensors coupled to the device are a combination of accelerometers, gyroscopes, IMUs, or other motion-based sensors.
  • the sensors coupled to the device also include electromyography (EMG) sensors to monitor muscle activation in order to sense tremor severity, rigidity, or movement due to RLS.
  • EMG electromyography
  • the device collects data on the characteristics of the user’s symptoms, such as motion amplitude and frequency or muscle activity with sensors contained in the device such as an accelerometer, pressure sensors, force sensors, gyroscope, Inertial Measurement Unit (IMU), or electromyography (EMG) sensors.
  • sensors contained in the device such as an accelerometer, pressure sensors, force sensors, gyroscope, Inertial Measurement Unit (IMU), or electromyography (EMG) sensors.
  • the above-mentioned data would be stored through storage components contained within the device.
  • the above-mentioned data is regularly consolidated for the purpose of larger scale data analysis through a wired or wireless transfer of data to a larger storage location not on the device.
  • the actuators are resistive heating elements rather than vibration motors.
  • the actuators are vibration motors.
  • the actuators are electromagnets . In some embodiments, the actuators are electropermanent magnets. In some embodiments, the actuators are piezoelectric actuators. In some embodiments, the actuators are voice coil vibration motors. In some embodiments, the Attorney Docket No. ENR-001USCP3WO actuators are rotating eccentric mass vibration motors.
  • the actuators may include one or more sonic transducers. Sonic transducers may include, without limitation, ultrasonic transducers or other sonic transducers. Ultrasonic transducers may also be interchangeably referred to as “ultrasonic emitters” throughout this disclosure. Ultrasonic transducers in some embodiments may output a frequency of about 1 Hz to about 1 GHz.
  • One or more ultrasonic transducers may be configured to target specific parts of a user’s body and/or at specific frequency ranges. For instance, one or more ultrasonic transducers may be configured to output a low-frequency ultrasound.
  • a low-frequency ultrasound may include a frequency of about 20 kHz to about 100 kHz which may target larger nerve bundles, deep soft tissues, and/or joints of a user.
  • a frequency of about 20 kHz to about 100 kHz may provide deep tissue penetration with less superficial heating.
  • One or more ultrasonic transducers may be configured to output a medium- frequency ultrasound.
  • a medium-frequency ultrasound may include a frequency of about 100 kHz to about 500 kHz.
  • a frequency of about 100 kHz to about 500 kHz may be used to target deeper nerves, muscles, tendons, and/or ligaments of a user.
  • a frequency of about 100 kHz to about 500 kHz may penetrate one or more tissues at intermediate depths and may affect structures like tendons and/or ligaments, may improve tissue perfusion, increase collagen extensibility, and potentially modulate nerve activity.
  • one or more ultrasonic transducers may be configured to output a high-frequency ultrasound.
  • a high- frequency ultrasound may include a frequency of about 500 kHz to about 1 MHz.
  • a frequency of about 500 kHz to about 1 MHz may target superficial nerves, tendons, and/or ligaments of a user and may offer high resolution imaging of one or more parts of a user.
  • a frequency of about 500 kHz to about 1 MHz may be used to target tissues closer to a skin surface of a user and may be used for localized treatments.
  • one or more ultrasonic transducers may be configured to output a diagnostic ultrasound.
  • a diagnostic ultrasound may include a frequency of about 1 MHz to about 10 MHz.
  • a frequency of about 1 MHz to about 10 MHz may provide imaging and visualization of soft tissues, organs, and/or superficial nerves.
  • a frequency of about 1 MHz to about 10 MHz may provide for diagnostic imaging without therapeutic effects.
  • one or more ultrasonic transducers may be configured to output a very high- frequency ultrasound.
  • a very high-frequency ultrasound may include a frequency of about or greater than 10 MHz.
  • a frequency at about or greater than 10 MHz may target superficial structures such as skin layers and nerves close to a skin surface.
  • a frequency at about or greater Attorney Docket No. ENR-001USCP3WO than 10 MHz may provide for ultra-high resolution imaging for dermatology, superficial nerve assessments, and/or visualization of superficial skin conditions.
  • two or more ultrasonic transducers may be used.
  • Ultrasonic transducers may include piezoelectric, capacitive, or other transducers.
  • one or more ultrasonic transducers may be configured to apply a waveform output to a part of a user.
  • a waveform output of one or more ultrasonic transducers may be about 1MHz in frequency.
  • the actuators may include electric transducers.
  • Electric transducers may include, without limitation, piezoelectric, capacitive, or other transducers. Electric transducers may be configured to output an electrical signal to a part of a user. For instance, and without limitation, electric transducers may be configured to output an AC (alternating current), DC (direct current), or other signal to a user. One or more electric transducers may be configured to output a waveform with a voltage of about 1v to about 5v, a current of about 10mA to about 50mA, and a frequency of about 50Mhz, without limitation. One or more electric transducers may be configured to perform transcutaneous electrical nerve stimulations (TENS), functional electric stimulations (FES), and/or other stimulations.
  • TESS transcutaneous electrical nerve stimulations
  • FES functional electric stimulations
  • One or more electric transducers may be configure d to output amps in a range of about, but not limited to 1 mA to about 80 mA. In some embodiments, one or more electric transducers may be configured to output a voltage of about 0V to about 50V. One or more electric transducers may be configured to output a frequency of about 1Hz to about 100 Hz. In some embodiments, one or more electric transducers may be configured to output a frequency of about 100 Hz to about 10,000 Hz. One or more electric transducers may be configured to provide conventional TENS, high-frequency or burst TENS, and/or modulation TENS.
  • One or more electric transducers may be configured to output time-varying frequencies, square waveforms, pulse waveforms, and the like of one or more voltages, currents, and the like.
  • One or more electric transducers may be configured to provide an intensity calibration of a stimulation for a user.
  • an intensity range of about 1 mA to about 5 mA may be used initially and may gradually increase until one or more parameters are met, such as if a user feels a tingling or mild muscle twitching.
  • a current may be adjust to about 10 mA to about 80 mA, depending on a treatment area and a patient’s comfort.
  • Electrodes of one or more electric transducers may have one or more electrodes. Electrodes of one or more electric transducers may include shapes, sizes, dimensions, and the like. For instance, electrodes may include shapes such as, but not limited to, square, rectangular, round, butterfly, and the like. Electrodes of one or more electric transducers may have a small size of about 2 cm by cm to about 5 cm by 5 cm. Electrodes may have a medium size of about 5 cm by 5 cm to about 10 cm by 5 cm. Electrodes may have a large size of about 10 cm by 5 cm or greater. Electrodes of one or more electric transducers may include material such as, but not limited to, carbon rubber electrodes, silver-based electrodes, and the like.
  • Electrodes of one or more electric transducers may have a resistance of about 1,000 ohms to about 5,000 ohms, without limitation. In some embodiments, electrodes of one or more electric transducers may have a resistance less than 1,000 ohms or greater than 5,000 ohms, without limitation.
  • the device is an accessory band to a third-party smartwatch or other wearable computing device. In some embodiments, the device can connect wirelessly (for example via Bluetooth) to the user’s smartphone. In some embodiments, the device can be configured to provide contextualized data about the user’s condition. For example, the system can correlate symptom onset or degree with time of day, activity level, medication, diet, other symptoms, etc.
  • this can be accomplished by transmitting extracted sensor signal features to the user’s smartphone.
  • An accompanying smartphone application can periodically prompt the user to input other information like activity level, diet, and medication. The application then logs this data with time matched symptom sensor signal features to be reviewed by the user and/or their physician.
  • the device can be started by passive sensing of the onset of symptoms such as the on/off phenomenon of Parkinson’s patients taking L-dopa. In some embodiments, this can be accomplished by continuously reading sensor data, even while in the “off” state, and then switching to the “on” state when one of the sensor data features, such as amplitude, surpasses a preset threshold value.
  • the device can be used to amplify an existing but subtle tremor for the purpose of early diagnosis. In some embodiments, this can be accomplished by manually testing a set of stimulation patterns until the tremor is apparent, either visually or as detected by an extracted feature of the sensor data surpassing some preset threshold. In some embodiments, this can be accomplished autonomously by inverting the stimulation selection algorithm heuristic such that it converges to Attorney Docket No. ENR-001USCP3WO the stimulation pattern which maximizes tremor amplitude as measured by the symptom sensor relative to the tremor amplitude measured in the absence of stimulation from the device.
  • Fig.1 illustrates a system for mitigating movement disorder in accordance with an embodiment of the present invention.
  • Fig.1 shows a wearable device 11 interfacing with a user’s body 12.
  • the user’s body 12 includes proprioceptive nerves 1201, perceived limb position and motion 1202, a nervous system 1203, desired activation control signal 1204, and muscles 1205.
  • the muscles 1205 output electrical activity 14, which is detected by the EMG sensor 1107 in the wearable’s sensor suite 1106, and collected as local data 1103.
  • the muscles 1205 also output motion 15, which is detected by the inertial measurement unit (IMU) 1108.
  • the IMU 1108 measures the body’s specific force, angular rate, and orientation, and reports to the processing unit 1101.
  • the processing unit 1101 receives the local data 1103 and executes a local algorithm 1102.
  • the processing unit 110 Using the local data 1103, the processing unit 110, based on results of the local algorithm 1102, instructs the mechanical transducers 1105 to deliver a specific vibrational stimulus 13.
  • the processing unit 110 may instruct one or more ultrasonic, electric, or other transducers to deliver an output to one or more proprioceptive nerves 1201.
  • the processing unit 110 may deliver a sound wave to one or more proprioceptive nerves 1201 through one or more ultrasonic transducers.
  • the processing unit 110 may instruct one or more electric transducers to deliver an output of electric energy to one or more proprioceptive nerves 1201.
  • the processing unit 110 may instruct a combination of ultrasonic, electric, and/or mechanical transducers to apply outputs of mechanical, audible, and/or electrical energy to one or more proprioceptive nerves 1201.
  • the processing unit 110 may alternatively, without limitation, cycle through one or more types of transducers that may be employed. For instance and without limitation, the processing unit 110 may cycle through a set of mechanical transducers to apply vibrational stimulus 13 to the proprioceptive nerves 1201 for a period of time, then through a set of electrical transducers for a period of time, and then through a set of ultrasonic transducers for a period of time.
  • the processing unit 110 may adjust one or more outputs of one or more mechanical, ultrasonic, and/or electrical transducers based on feedback received from one or more sensors, such as the IMU 1108 and/or the EMG sensor 1107.
  • the proprioceptive nerves 1201 detect the vibrational stimulus 13 and send the perceived limb position and motion 1202 to the nervous system 1203. Based on that signal, the nervous system 1203 sends a desired activation control signal 1204 to activate the Attorney Docket No. ENR-001USCP3WO muscles 1205 in a way that either alters or perpetuates their electrical activity 14 and motion 15.
  • the local data 1103 collected by the sensor suite 1106 continues to be processed by the local algorithm 1102 again, and continues to affect the output of the mechanical transducers 1105.
  • the local data 1103 is also transmitted via the communication module 1104 to a remote processing algorithm 16, and to a remote database 18 for long-term data storage and access by researcher 19.
  • the remote database 18 also receives data from the greater population, or the crowd 17, and sends this data to the remote processing algorithm 16.
  • the remote processing algorithm 16 analyzes the data and returns the results of the analysis both to the processing unit 1101, via the communication module 1104, and also to the crowd 17. In this way, data from the crowd 17 may influence the way that the local algorithm 1102 operates.
  • Fig.2 is an electrical schematic highlighting the main sub-circuits of the system in Fig.1.
  • Fig.2 shows the processing unit 1101, which receives tremor vibration data from the inertial measurement unit 1108 in the inertial measurement unit circuit 24.
  • Fig.3 is an isometric view of a wearable device in accordance with an embodiment of the present invention.
  • Fig.3 shows the main electronics housing 32 of the device and the band 31 of the device that interfaces with the user’s wrist.
  • Fig.4 is an exploded isometric view of a wearable device, in which the vibration motors are housed in the band rather than in the main electronics housing, in accordance with an embodiment of the present invention.
  • the mechanical transducers 1105 are housed in the band 31 which interfaces with the user's wrist. In some embodiments, the mechanical transducers 1105 may be replaced with ultrasonic, electric, or other transducers.
  • PCB printed circuit board
  • the battery 26 includes protection circuitry to protect from overcharging and unwanted discharging.
  • a magnetic plug-in head 421 is inserted into the PCB 42.
  • the magnetic plug-in head 421 allows patients who have difficulty performing tasks that require fine motor skills to easily charge the device with a magnetic charging cable.
  • the device is intended to work after the patient turns the device on by pressing the single, large button 323 on top of the electronic housing top 321.
  • the button is provided for ease of use by a patient whose fine motor control is affected by a neurological movement disorder.
  • Fig.5 is an isometric view of a wearable device, in which the device includes a loop mechanism 51 to allow single handed adjustment of the band 31 on the user’s wrist, in accordance with an embodiment of the present invention.
  • Fig.5 shows the main electronics housing 32, the band 31 as it looks when worn on the user’s wrist, and an adjustment mechanism 51 that is integrated into the main electronics housing 32.
  • Fig.6 shows an embodiment of the present invention worn on a hand viewed from above.
  • Fig.6 shows the main electronics housing 32 and the band 31 that interfaces with the user’s wrist.
  • Fig.7 shows an embodiment of the present invention worn on a hand viewed from the side.
  • Fig.7 shows the main electronics housing 32, the band 31 that interfaces with the user’s wrist, and the on/off button 323 that a patient may use to begin/stop the vibrational stimulation.
  • the on/off button 323 is integrated into the main electronics housing 32.
  • Fig.8 shows a testing configuration for the wearable medical device, which may be used for more rigorous data collection, in accordance with an embodiment of the present invention.
  • Fig.8 shows the main electronics housing 32 and the band 31 that interfaces with the user's wrist. These are connected to a data logging apparatus 81 which collects and stores data. Data can continue to be collected and stored over a larger time scale than on the device alone, as this testing configuration is equipped with a larger processor and storage capacity.
  • Fig.9 illustrates a wearable device for mitigating movement disorder, in which the device is an accessory to a third-party smartwatch or other wearable computing device 91, in accordance with an embodiment of the present invention.
  • some or all of the computation 912 and sensing 911 are offloaded to the third-party wearable device 91.
  • the third-party device then sends a set of motor commands wirelessly 94 (over Bluetooth for Attorney Docket No. ENR-001USCP3WO example 913925) to a processing unit 1101 on the accessory band 92.
  • This processing unit 1101 interfaces with the transducers 1105 on the band to execute the desired motor commands.
  • the accessory band 92 has its own battery 925.
  • the band also has its own specialized sensors 923 (such as electromyography sensors), the signals of which are communicated to the third-party processing unit 912 via the accessory processing unit 1101, and wireless communication 91392594. Data may also be logged to the user’s smartphone over the same wireless connection 94.
  • Fig.10 shows a side view of a wearable device, which is as an accessory band for a third-party smartwatch or other wearable computing device, in accordance with an embodiment of the present invention. It shows the main electronics housing 32 and the band 31 which contains the mechanical transducers 1105.
  • Fig.11 shows a process by which a raw sensor input may be used to compute a set of stimulation parameters in accordance with an embodiment of the present invention.
  • the stimulation parameters are continuously updated in closed loop. These parameters can include any quantities used to define a stimulation waveform such as frequency, amplitude, phase, duty cycle, etc.
  • the current stimulation parameters 111 and raw sensor input 112 are used to filter out transducer/sensor crosstalk 113 either by using knowledge of the output waveform to subtract from the sensed waveform or by using knowledge of the timing of the output waveform to limit sensing to the “off” phases of a pulsing stimulation.
  • This filtering subsequently allows for feature extraction 114 of the raw sensor input 112.
  • the stimulation selection algorithm 115 uses the current stimulation parameters 111 and the extracted features 114 to select new stimulation parameters 116. This process is illustrated in greater depth in Figure 13.When the process repeats, the previously new stimulation parameters 116 become to the current stimulation parameters 111.
  • Fig.12 shows a feature extraction process in accordance with an embodiment of the present invention.
  • This process takes in a filtered sensor signal, as described with respect to Fig.11, and extracts temporal 114111421143 and/or spectral features 1144.
  • Examples of common temporal features include the minimum value, the maximum value, first three standard deviation values, signal energy, root mean squared (RMS), zero crossing rate, principal component analysis (PCA), kernel or wavelet convolution, or autoconvolution.
  • Examples of Attorney Docket No. ENR-001USCP3WO common spectral features include the Fourier Transform, fundamental frequency, (Mel- frequency) Cepstral coefficients, the spectral centroid, and bandwidth.
  • Features are extracted with standard digital signal processing techniques onboard the main processing unit of the device. The set of collected features is then fed into the stimulation selection algorithm.
  • Fig.13 shows a stimulation optimization algorithm in accordance with an embodiment the present invention.
  • the stimulation selection algorithm takes in the extracted features 114 and the current stimulation parameters 111 and uses them to determine the set of new stimulation parameters 116.
  • the process by which the new parameters are determined is an optimization to minimize the symptom severity. Given that there is no analytical model for the symptom’s response to stimulation patterns, this optimization is inherently model free. Examples of model free policy optimization techniques are argmin (or minimization over the set of input arguments), Q-learning, neural networks, genetic algorithms, differential dynamic programming, iterative quadratic regulator, and guided policy search. Descriptions of some such algorithms can be found in Deisenroth, M. P.
  • an extracted feature may be the amplitude of the tremor and the set of current stimulation parameters could be a stimulation frequency and amplitude.
  • a stimulation selection algorithm can then compare the tremor amplitude observed with the current set of stimulation parameters to the tremor amplitude observed with a previous set of stimulation parameters to determine which of the two sets of stimulation parameters resulted in the lowest tremor amplitude.
  • the set with the lowest resulting tremor amplitude could then be used as the baseline for the next iteration of the stimulation selection algorithm which would compare it to a new set.
  • Two example stimulation selection algorithms that may be used in embodiments follow: Attorney Docket No. ENR-001USCP3WO
  • the structure of the output stimulation pattern may be a weighted average of optimized patterns corresponding to each symptom where the weights are proportional to the symptom severity relative to the other observed symptoms.
  • Fig.14 shows a neurological signal cancelling system, illustrating how the wearable 11 device and body 12 interact, in accordance with an embodiment of the present invention.
  • the system comprises of the user’s nervous system 1203, which sends control signals 141 to the body 12.
  • the wearable 11 senses the body’s movement and sends an opposing control Attorney Docket No. ENR-001USCP3WO signal which is defined by the output of the stimulation parameter selection algorithm.142.
  • the control signals undergo a signal cancelling process within the nervous system of the user 143, which results in a smoother perceived motion signal 143.
  • Fig.15 is a pair of renderings 151152 by a tremor patient of an Archimedes spiral under conditions without and with treatment by a device in accordance with an embodiment of the present invention.
  • the spiral tracing test allows doctors to gain insight on the frequency, amplitude, and direction of their patients’ tremors. It can also inform the doctor of abnormal movement of hypokinesia, dystonia, and tremor.
  • the task requires the patient to continuously trace the Archimedes spiral. Patients who have tremors will have difficulty following the spiral and will trace off the spiral line resulting in a disordered spiral 151. Wearing a device in accordance with an embodiment of the present invention, the patient is able to trace the spiral more accurately resulting in a smoother spiral 152.
  • Fig.16 illustrates an embodiment of a simple non-convex gradient descent optimization used in embodiment of the present invention for symptom reduction by searching over the parameter configuration space. It is a graphical representation of the stimulation selection algorithm 163 associated with the present invention.
  • the algorithm 163 moves through the stimulation parameter space 162 and attempts to minimize symptom severity 161.
  • the movement through the stimulation parameter space can be thought of as trying different sets of stimulation parameters and comparing their resulting symptom severities as quantified by their respective sensors.
  • the algorithm attempts to minimize symptom severity by testing different sets of parameters until an optimal set for minimizing symptom severity is found.
  • Alternative benchtop versions of the device can be used to elicit tremors in Parkinson’s patients for the purposes of early detection.
  • Figs.17 and 18 each shows a power spectral density (PSD) plot of the postural tremor of a Parkinson’s Disease and Essential Tremor patient, respectively, with and without the use of a device in accordance with an embodiment of the present invention. The data was taken Attorney Docket No.
  • ENR-001USCP3WO by asking each patient to hold his or her hand out for 10 seconds, with and without the device.
  • Figs.17 and 18 tremor amplitude is compared with and without the device.
  • the following describes a test case of an embodiment of the present invention. Participants were asked to trace a printed Archimedes Spiral, a common test used to diagnose Parkinson's, with and without the device, as shown in Fig.15. The results were measured by using image processing software to evaluate the accuracy of the traced spirals. In the first round of testing, the device was tested on around 20 participants with Parkinson's and 1 participant with a resting tremor.

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Abstract

Une bande multimodale pouvant être portée qui utilise des vibrations mécaniques pour stimuler les neurones sensoriels dans le poignet ou la cheville afin de réduire la sévérité des tremblements, de la rigidité, des contractions musculaires involontaires et de la bradykinésie provoqués par des troubles neurologiques du mouvement et de libérer les utilisateurs de l'immobilisation induite par des troubles du mouvement. Le dispositif utilise des capteurs afin de fournir une sortie utilisée par une unité de traitement pour déterminer le motif de stimulation optimal pour chaque utilisateur et pour déterminer à quel moment une stimulation est nécessaire, et utilise ensuite un ou plusieurs moteurs de vibration pour stimuler de manière correspondante les voies neurologiques de l'utilisateur afin de réduire la sévérité des symptômes de l'utilisateur. Le dispositif peut également être conçu pour s'intégrer à des dispositifs tiers.
PCT/US2024/041732 2023-08-11 2024-08-09 Appareil et procédé de réduction de symptômes de troubles neurologiques du mouvement à l'aide d'un dispositif pouvant être porté Pending WO2025038457A1 (fr)

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